Summary
The historic but minimally supported enthusiasm for the Sequenom prenatal test has previously been reported in this space previously. Even in the absence of data retractions, leading to termination of much of senior management, problems in the rollout of the product should have been anticipated.
Remarkably, this article asserts that industry insiders remain optimistic about the development of a successful diagnostic product.
Analysis
From the historical perspective of claims for, and valuation of a laboratory test, the Sequenom story is quite unique. A publicly traded company reached valuations of nearly $1 billion, in the absence of any peer reviewed clinical data. See:
http://www.glgroup.com/News/Jumping-off-the-Bandwagon---Decline-in-Sequenom-shares-takes-world-by-surprise-38221.html
The only reported data was done by press release. All such data has since been retracted, and much of the companies leadership has been terminated. Details of what actually happened, if in fact there is any reasonable basis for a product, and where the process went awry, have not been made public.
Regardless, this article asserts that:
"most industry insiders with whom I’ve spoken say the DNA-based assay, which is designed to test for trisomy 21, could be a winner if given the chance to shine in a properly run trial".
It would be helpful if such insiders would clarify the basis for such optimism
From my perspective as an outsider, whatever issues existed prior to April 30, 2009 have only been exacerbated. Presumably an institutional review board (IRB) overseeing a properly run clinical trial would want to see high quality peer reviewed data prior to permitting a trial to begin. Furthermore, in the absence of any data, there is no reason for anyone to assume a trial will show good results. At some point in this discussion, a clinical trial is referred to as if it were a pro forma regulatory hurdle, and not a high risk, bet the company, event.
For further information on the clinical, regulatory, and legal issues that would need to be overcome for this product to generate meaningful revenue in the foreseeable future, please contact your GLG representative.
